Babycom
510(k) K013547
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013547 | Date20 Feb 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNG
- FDA applicant
- Pmg Medica , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2660
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Babycom Ultrasonic Fetal Heart Rate Monitor is a Class II medical device designed for obstetric use. It employs ultrasonic technology to detect and display the fetal heart rate, enabling real-time monitoring of fetal cardiac activity during pregnancy. This device is classified under the FDA’s regulation number 21 CFR 884.2660 and is intended for use in obstetrics and gynecology settings.
The monitor is supplied as a reusable device and is intended for clinical use in obstetric environments. It operates under FDA clearance (510(k) K013547) and has been determined substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data. The device is manufactured by PMG Medica, Ltd., and includes multiple FEI numbers for regulatory tracking, though no explicit storage or handling instructions are detailed in the specifications.
Questions
AI-generated answers, 1 Oct 2026
What is the Babycom Ultrasonic Fetal Heart Rate Monitor used for?
The Babycom Ultrasonic Fetal Heart Rate Monitor is designed specifically for obstetric use to detect and display the fetal heart rate in real-time. It employs ultrasonic technology to monitor fetal cardiac activity during pregnancy, providing clinicians with immediate feedback on the baby’s heart rate. This is particularly useful in obstetrics and gynecology settings to ensure the well-being of the fetus.
Is the Babycom monitor reusable or single-use?
The Babycom Ultrasonic Fetal Heart Rate Monitor is supplied as a reusable device. This means it is intended for repeated use in clinical settings, provided proper cleaning and maintenance protocols are followed. Reusability helps reduce waste and costs in healthcare environments.
What regulatory approval does the Babycom monitor hold?
The Babycom monitor holds FDA clearance under the 510(k) pathway, specifically with clearance number K013547. It is classified under FDA regulation number 21 CFR 884.2660 and is determined to be substantially equivalent to a predicate device. This clearance confirms its compliance with U.S. safety and performance standards for obstetric monitoring devices.
Are there any specific storage or handling instructions for the Babycom?
The provided data does not include explicit storage or handling instructions for the Babycom monitor. However, as a reusable medical device, it should be stored in a clean, dry environment to prevent contamination and damage. Proper cleaning and disinfection protocols should be followed after each use to ensure hygiene and functionality.
Does the Babycom monitor have any special considerations for sterility or MRI safety?
The available data does not specify whether the Babycom monitor is sterile or includes any MRI safety information. Clinicians should follow standard infection control practices for reusable medical devices and verify compatibility with their facility’s MRI protocols if used in such environments.